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FDA 510(k)

ArtiSential Bipolar Fenestrated Forceps

K-Number: K190909 · 2020-02-13

ApplicantLivsmed, Inc.
Decision Date2020-02-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ArtiSential Bipolar Fenestrated Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K190909. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtiSential Bipolar Fenestrated Forceps?

ArtiSential Bipolar Fenestrated Forceps is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Livsmed, Inc.. The 510(k) number is K190909.

When did ArtiSential Bipolar Fenestrated Forceps receive FDA 510(k) clearance?

ArtiSential Bipolar Fenestrated Forceps received FDA 510(k) clearance on 2020-02-13, under 510(k) number K190909.

Who is the listed applicant for ArtiSential Bipolar Fenestrated Forceps?

The FDA 510(k) record lists Livsmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtiSential Bipolar Fenestrated Forceps?

The FDA product code for ArtiSential Bipolar Fenestrated Forceps is GEI.

Other records listing Livsmed, Inc. as applicant

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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